This project examines ethical issues related to the use of humans in genetics research and to the use of genetic technologies and services in the health care system. The project utilizes two broad approaches to address these issues: (1) conceptual projects that clarify distinctions and develop theoretical frameworks for evaluating ethical issues; and (2) empirical social science projects that involve collecting and analyzing data for addressing these issues. The two approaches are complementary, and many sub-projects utilize components of both approaches. One branch of this project focuses on ethical issues related to using humans in genetic research. This branch currently includes studies related to describing how research participants and investigators understand the benefits of gene transfer research, using a novel technique of ?decision monitoring? to augment informed consent in gene transfer research, assessing public attitudes about participating in genetic research that involves providing a blood sample and clinical information, identifying criteria for determining which genetic research results should be returned in research participants, and evaluating the ethical issues likely to emerge with large scale medical sequencing research. During this past year, research findings in the human subjects research branch include papers assessing preferences of family members for recruitment in research, describing the content of consent forms in genetic research, describing the content of consent forms for gene transfer research, assessing relationship between the understanding of the benefits of gene transfer research by study personnel, study participants, and consent forms, analyzing the ethical issues in conducting newborn screening research, and evaluating the risk-benefit ratio in genetic health services research. The second branch of this project focuses on the ethical and policy issues relations to the integrations of clinical genetics services in to the health care system. One group of projects involves empirical evaluations of offering novel genetic tests in primary care settings, including two projects related to colon cancer risk. A second group of projects involve conceptual analyses of the public health implications of direct to consumer marketing of genetic tests. This past year, research findings related to this branch include papers describing policy approaches utilized by states for cystic fibrosis newborn screening, analysizing about the ethical issues in balancing benefits and risks determining cystic fibrosis newborn screening policy, describing the marketing of carrier screening panels for Askenazi Jews, and analysizing the implications of broadening the traditional public health criteria for newborn screening.